ChiCTR2600126954 版本V1.0 版本创建时间2026/06/21 22:12:06 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600126954 

最近更新日期：

Date of Last Refreshed on：

2026-06-21 22:10:32 

注册时间：

Date of Registration：

2026-06-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

水乐檬辅助改善儿童急性上呼吸道病毒感染症状及促进恢复的临床研究

Public title：

Clinical Study on the Auxiliary Improvement of Symptoms and Recovery in Children with Acute Upper Respiratory Tract Viral Infections Using Shui Lemong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

水乐檬辅助改善儿童急性上呼吸道病毒感染症状及促进恢复的临床研究

Scientific title：

Clinical Study on the Auxiliary Improvement of Symptoms and Recovery in Children with Acute Upper Respiratory Tract Viral Infections Using Shui Lemong

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

俞璐 

研究负责人：

俞璐 

Applicant：

Yu Lu 

Study leader：

Yu Lu 

申请注册联系人电话：

Applicant telephone：

+86 510 68562215

研究负责人电话：

Study leader's telephone：

+86 510 68562215

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

kcsjzjd_2008@sina.com

研究负责人电子邮件：

Study leader's E-mail：

kcsjzjd_2008@sina.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

江苏省无锡市兴源北路585号

研究负责人通讯地址：

中山路68号，兴源北路585号

Applicant address：

No. 585, Xingyuan North Road, Wuxi City, Jiangsu Province

Study leader's address：

No. 68 Zhongshan Road, Wuxi City,585 Xingyuan North Road, Wuxi City

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

无锡市第二人民医院

Applicant's institution：

Wuxi Second People's Hospital

研究负责人所在单位：

无锡市第二人民医院

Affiliation of the Leader：

Wuxi No.2 People’s Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

WXEY-2026-104

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

无锡市第二人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2026-05-26 00:00:00

伦理委员会联系人：

曹珺

Contact Name of the ethic committee：

Cao Jun

伦理委员会联系地址：

中山路68号，兴源北路585号

Contact Address of the ethic committee：

No. 68 Zhongshan Road, Wuxi City,585 Xingyuan North Road, Wuxi City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 510 68563050

伦理委员会联系人邮箱：

Contact email of the ethic committee：

wxeyywc@163com

研究实施负责（组长）单位：

无锡市第二人民医院

Primary sponsor：

Wuxi No.2 People’s Hospital

研究实施负责（组长）单位地址：

中山路68号，兴源北路585号

Primary sponsor's address：

No. 68 Zhongshan Road, Wuxi City,585 Xingyuan North Road, Wuxi City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

无锡市第二人民医院

具体地址：

中山路68号，兴源北路585号

Institution
hospital：

Wuxi No.2 People’s Hospital

Address：

No. 68 Zhongshan Road, Wuxi City,585 Xingyuan North Road, Wuxi City

经费或物资来源：

水乐檬辅助改善儿童急性上呼吸道病毒感染症状及促进恢复的临床研究

Source(s) of funding：

Jiangnan University Food Science College

Target disease：

Acute upper respiratory tract infection in children

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评估在标准化对症治疗基础上，每日两次饮用“金豆芽钙铁锌水乐檬”(150ml/次)，连续5天，能否缩短3-12岁急性上呼吸道感染儿童的核心症状持续时间。  

Objectives of Study：

To evaluate whether, based on standardized symptomatic treatment, drinking "Golden Bean Sprout Calcium Iron Zinc Lemon Water" (150ml per dose) twice daily for 5 consecutive days can shorten the duration of core symptoms in children aged 3-12 years with acute upper respiratory tract infection

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄在3-12周岁（包含两端），性别不限，其法定监护人及8周岁以上儿童本人均需签署知情同意书。本研究主要纳入处于疾病急性期、仅接受基础对症支持治疗或尚未接受系统性干预的患儿。
2.符合《诸福棠实用儿科学》（第九版）中关于急性上呼吸道感染的临床诊断标准，且自症状首次出现起算，病程不超过48小时。 （3）入组时必须伴有发热（腋下温度≥37.5℃）以及至少一项其他上呼吸道感染核心症状（如咳嗽、鼻塞、流涕或咽痛）。
3.入组时必须伴有发热（腋下温度≥37.5℃）以及至少一项其他上呼吸道感染核心症状（如咳嗽、鼻塞、流涕或咽痛）。

Inclusion criteria

1.Children aged 3 to 12 years (inclusive), regardless of gender, must have both their legal guardians and the children themselves (if aged 8 or older) sign an informed consent form. This study primarily includes pediatric patients in the acute phase of illness who are receiving only basic symptomatic supportive treatment or have not yet undergone systematic intervention.
2.Must meet the clinical diagnostic criteria for acute upper respiratory tract infection as defined in "Zhu Futang's Practical Pediatrics" (9th edition), and the duration of illness must not exceed 48 hours from the onset of symptoms. (3) At enrollment, patients must have fever (axillary temperature ≥37.5°C) along with at least one other core symptom of upper respiratory tract infection (such as cough, nasal congestion, rhinorrhea, or sore throat).
3.Participants must have a fever (axillary temperature ≥37.5°C) at enrollment, along with at least one other core symptom of upper respiratory tract infection (such as cough, nasal congestion, runny nose, or sore throat).

排除标准：

1.符合重型/危重型早期预警指标：儿童危重症评分（PEWS）≥4分。
2.明确或高度怀疑为细菌感染，需立即使用抗菌药物者；
3.合并严重基础疾病（如先天性心脏病、免疫缺陷病、慢性肝肾疾病、糖尿病等）。
4.对柑橘类水果或试验饮品任何成分过敏者。
5.入组前24小时内已服用其他维生素C补充剂或电解质饮料。
6.筛选前 30 天内参加过其他临床研究者。
7.研究者认为不适宜参加本临床研究者。

Exclusion criteria：

1.Meets the early warning indicators for severe/critical cases: Pediatric Critical Illness Score (PEWS) >= 4 points. 2.Those who are clearly diagnosed or highly suspected of having bacterial infection and require immediate use of antibacterial drugs. 3.Including severe underlying diseases (such as congenital heart disease, immunodeficiency disorders, chronic liver and kidney diseases, diabetes, etc.). 4.Those who are allergic to any component of citrus fruits or the test beverage. 5.Within 24 hours prior to enrollment, the participant had already taken other vitamin C supplements or electrolyte beverages. 6.Screen those who have participated in other clinical studies within the past 30 days. 7.The researchers considered that the participants were not suitable for this clinical study.

研究实施时间：

Study execute time：

从 From 2026-07-01 00:00:00至 To 2027-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-07-01 00:00:00 至 To 2027-12-01 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

120

Group：

control group

Sample size：

干预措施：

不干预

干预措施代码：

Intervention：

nonintervention

Intervention code：

组别：

试验组

样本量：

120

Group：

experimental group

Sample size：

干预措施：

每日两次饮用“金豆芽钙铁锌水乐檬”(150ml/次)，连续5天

干预措施代码：

Intervention：

Drink "Golden Bean Sprout Calcium Iron Zinc Lemon Water" (150ml each time) twice a day for 5 consecutive days

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China 

Province：

Jiangsu 

City：

 

单位(医院)：

无锡市第二人民医院 

单位级别：

三级甲等 

Institution
hospital：

Wuxi No.2 People’s Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

症状持续时间（小时）

指标类型：

主要指标

Outcome：

Duration of symptoms (hours)

Type：

Primary indicator

测量时间点：

D0（基线）、D1～D6每晚、D7±1（结束随访）

测量方法：

儿童感冒症状问卷（CCSQ）

Measure time point of outcome：

D0 (baseline), D1 to D6 every night, D7 ± 1 (end of follow-up)

Measure method：

Childhood Cold Symptom Questionnaire

指标中文名：

不良反应发生率

指标类型：

次要指标

Outcome：

Incidence of adverse reactions

Type：

Secondary indicator

测量时间点：

D0至D7全程

测量方法：

记录研究期间所有不良事件（AE），包括胃肠道反应（恶心、呕吐、腹泻）和过敏反应（皮疹、血管性水肿等），按CTCAE v5.0标准进行严重程度分级，并评估与研究饮品的相关性。采用卡方检验比较两组AE发生率。

Measure time point of outcome：

From D0 to D7

Measure method：

Record all adverse events (AE) during the study period, including gastrointestinal reactions (nausea, vomiting, diarrhea) and allergic reactions (rash, angioedema, etc.), and grade their severity according to the CTCAE v5.0 standard. Assess their correlation with the study beverages. Use the chi-square test to compare the incidence of AE between the two groups.

指标中文名：

单项症状消失时间及消失率

指标类型：

次要指标

Outcome：

The time of disappearance and the disappearance rate of individual symptoms

Type：

Secondary indicator

测量时间点：

D0至D7每日

测量方法：

定义为各单项症状（咳嗽、鼻塞、流涕、咽痛、发热等）CCSQ评分降至0分且维持≥24小时所需时间（小时）；消失率为D5、D7时点症状评分为0分的研究参与者比例。以均数±标准差或中位数描述消失时间，采用独立样本t检验（或Mann-Whitney U检验）比较组间差异；采用卡方检验比较消失率。

Measure time point of outcome：

D0 to D7 daily

Measure method：

Defined as the time (in hours) required for each individual symptom (cough, nasal congestion, runny nose, sore throat, fever, etc.) to reach and maintain a CCSQ score of 0 for at least 24 hours; disappearance rate refers to the proportion of study participants whose symptoms scored 0 at the D5 and D7 time points. Disappearance time was described using mean ± standard deviation or median, and group differences were compared using independent samples t-test (or Mann-Whitney U test); chi-square tes

指标中文名：

炎症因子IL-6变化

指标类型：

次要指标

Outcome：

Change of inflammatory factor IL-6

Type：

Secondary indicator

测量时间点：

D0至D7全程

测量方法：

血清IL-6（pg/mL）较D0基线的变化值，采用ELISA法检测。于D0（基线）及D7±1（结束访视）抽取静脉血检测，采用配对t检验评估组内前后变化（D0与D7±1），采用独立样本t检验（或Mann-Whitney U检验）比较两组D7±1变化值差异。

Measure time point of outcome：

From D0 to D7

Measure method：

The change in serum IL-6 (pg/mL) compared to the baseline at D0 was measured using the ELISA method. Venous blood was drawn at D0 (baseline) and D7 ± 1 (end visit) for testing. Paired t-test was used to evaluate the intra-group changes (D0 vs. D7 ± 1), and independent sample t-test (or Mann-Whitney U test) was used to compare the differences in the change values between the two groups at D7 ± 1.

指标中文名：

每日症状严重程度评分较基线变化

指标类型：

次要指标

Outcome：

Daily symptom severity score changes from baseline

Type：

Secondary indicator

测量时间点：

D0（基线）、D1～D6每晚、D7±1。

测量方法：

包括发热、咳嗽、鼻塞、流涕各单项CCSQ评分及总症状评分（TSS）较D0基线的变化值（Δ分），以各时点两组评分均值±标准差进行描述，各时点采用独立样本t检验（或Mann-Whitney U检验）比较组间差异，并计算各时点较基线的变化值（Δ分）。

Measure time point of outcome：

D0 (baseline), D1 to D6 every night, D7±1.

Measure method：

The changes in individual CCSQ scores (for fever, cough, nasal congestion, and runny nose) and the total symptom score (TSS) compared to the baseline at D0 were presented as the difference values (Δ points). The scores at each time point were described using the mean ± standard deviation of the two groups. The differences between the groups at each time point were compared using the independent sample t-test (or Mann-Whitney U test), and the change values compared to the baseline at each time po

指标中文名：

血电解质水平变化

指标类型：

次要指标

Outcome：

Changes in blood electrolyte levels

Type：

Secondary indicator

测量时间点：

D0至D7全程

测量方法：

包括血钠（Na+）、钾（K+）、氯（Cl-）、钙（Ca2+）较D0基线的变化值（Δmmol/L）。于D0（基线）及D7±1（结束访视）抽取静脉血检测，采用配对t检验评估组内前后变化（D0与D7±1），采用独立样本t检验（或Mann-Whitney U检验）比较两组D7±1变化值差异。

Measure time point of outcome：

From D0 to D7

Measure method：

Including the change values (Δmmol/L) of blood sodium (Na+), potassium (K+), chloride (Cl-), and calcium (Ca2+) compared to the D0 baseline. Venous blood was drawn at D0 (baseline) and D7 ± 1 (end visit) for testing. Paired t-test was used to evaluate the intra-group changes (D0 vs. D7 ± 1), and independent sample t-test (or Mann-Whitney U test) was used to compare the differences in the change values between the two groups at D7 ± 1.

指标中文名：

C反应蛋白（CRP）变化

指标类型：

次要指标

Outcome：

Change in C-reactive protein (CRP)

Type：

Secondary indicator

测量时间点：

D0至D7全程

测量方法：

血清CRP（mg/L）较D0基线的变化值，于D0（基线）及D7±1检测，描述性统计报告各项指标均值±标准差及变化量，采用独立样本t检验（或Mann-Whitney U检验）比较两组终点差异。

Measure time point of outcome：

From D0 to D7

Measure method：

The change in serum CRP (mg/L) compared to the baseline at D0 (the initial point) was measured at D0 (baseline) and D7 ± 1. Descriptive statistics reported the mean ± standard deviation of each indicator and the change amount. Independent sample t-test (or Mann-Whitney U test) was used to compare the differences between the two groups at the endpoints.

指标中文名：

5天内症状反复或加重发生率

指标类型：

次要指标

Outcome：

The incidence rate of symptoms recurring or worsening within 5 days

Type：

Secondary indicator

测量时间点：

D1～D5每日

测量方法：

定义为D1～D5期间出现症状在一度缓解后再次加重（任意单项CCSQ评分较前一日增加≥1分）的研究参与者比例。采用卡方检验比较两组发生率。

Measure time point of outcome：

D1 to D5 every day

Measure method：

The proportion of study participants who experienced symptom recurrence (with any single CCSQ score increasing by ≥ 1 point compared to the previous day) after a period of initial symptom relief was defined as D1 to D5. Chi-square test was used to compare the incidence rates between the two groups.

指标中文名：

体温复常时间（小时）

指标类型：

次要指标

Outcome：

Recovery time of body temperature (hours)

Type：

Secondary indicator

测量时间点：

D0至D7每日

测量方法：

定义为首次服用研究产品后，腋下温度≤37.0℃且持续≥24小时所需时间。每日测量腋温，于当晚通过纸质日记卡记录当日最高体温；以均数±标准差或中位数描述两组体温复常时间，采用独立样本t检验比较组间差异；同时比较D7±1体温已复常的人数及比例（卡方检验）。

Measure time point of outcome：

From D0 to D7 every day

Measure method：

The definition is the time required for the first administration of the study product, during which the axillary temperature is ≤ 37.0℃ and remains so for ≥ 24 hours. Axillary temperatures are measured daily, and the highest temperature of the day is recorded on a paper diary card at night. The time for temperature recovery in both groups is described using the mean ± standard deviation or median. Independent sample t-tests are used to compare the differences between the groups.

指标中文名：

食欲恢复时间

指标类型：

次要指标

Outcome：

Recovery time of appetite

Type：

Secondary indicator

测量时间点：

D1至D7每日

测量方法：

定义为患儿食量恢复至平日食量80%以上的时间（小时），由监护人每日在电子日记卡中评估并记录。以均数±标准差或中位数描述食欲恢复时间，采用独立样本t检验（或Mann-Whitney U检验）比较组间差异；同时统计D7±1食欲已恢复（达平日80%以上）的比例，采用卡方检验比较。

Measure time point of outcome：

From D1 to D7 every day

Measure method：

The time (in hours) when the child's food intake returns to more than 80% of the normal level is defined. This is evaluated and recorded by the guardian on an electronic diary card every day. The time for appetite recovery is described using the mean ± standard deviation or the median. The differences between groups are compared using the independent sample t-test (or the Mann-Whitney U test). At the same time, the proportion of patients whose appetite has recovered by D7 ± 1 (reaching more than

指标中文名：

日均液体摄入量

指标类型：

次要指标

Outcome：

Daily average liquid intake

Type：

Secondary indicator

测量时间点：

D1～D5每日

测量方法：

由监护人每日在电子日记卡中记录患儿除研究饮品外的饮水量（白水、汤、奶等），计算D1～D5各日液体摄入量均值。采用独立样本t检验（或Mann-Whitney U检验）比较两组差异。

Measure time point of outcome：

D1 to D5 every day

Measure method：

The guardian was required to record the amount of water consumed by the child (excluding the research beverages) in the electronic diary card every day. The average liquid intake for each day from D1 to D5 was calculated. An independent sample t-test (or Mann-Whitney U test) was used to compare the differences between the two groups.

指标中文名：

血常规变化

指标类型：

次要指标

Outcome：

Changes in blood routine tests

Type：

Secondary indicator

测量时间点：

D0至D7全程

测量方法：

白细胞总数（WBC）、中性粒细胞比例（N%）、淋巴细胞比例（L%）较D0基线的变化值，于D0（基线）及D7±1检测，描述性统计报告各项指标均值±标准差及变化量，采用独立样本t检验（或Mann-Whitney U检验）比较两组终点差异。

Measure time point of outcome：

From D0 to D7

Measure method：

The changes in the total white blood cell count (WBC), the proportion of neutrophils (N%), and the proportion of lymphocytes (L%) compared to the baseline at D0 (the initial value) were measured at D0 (baseline) and D7 ± 1. Descriptive statistics reported the mean ± standard deviation of each indicator and the change values. Independent sample t-tests (or Mann-Whitney U tests) were used to compare the differences between the two groups at the end points.

指标中文名：

每日总体舒适度视觉模拟评分（VAS）较基线的变化

指标类型：

次要指标

Outcome：

The change in the daily overall comfort visual analogue scale (VAS) compared to the baseline

Type：

Secondary indicator

测量时间点：

D0至D7每日一次（晚）

测量方法：

由监护人每日通过电子日记卡记录患儿总体舒适度VAS评分（0～10分，0为极度不适，10为完全舒适），分析各时点较D0基线的变化值。各时点采用独立样本t检验（或Mann-Whitney U检验）比较两组评分及较基线变化值的差异。

Measure time point of outcome：

D0 to D7 once a day (in the evening)

Measure method：

The guardians record the overall comfort score of the child using an electronic diary card on a daily basis (on a scale of 0 to 10, with 0 indicating extreme discomfort and 10 indicating complete comfort). The changes from the baseline (D0) at each time point are analyzed. At each time point, an independent sample t-test (or Mann-Whitney U test) is used to compare the differences in scores between the two groups and the changes from the baseline.

指标中文名：

总病程

指标类型：

次要指标

Outcome：

Total course of illness

Type：

Secondary indicator

测量时间点：

D7±1随访期

测量方法：

定义为从症状首次出现至所有急性上呼吸道感染症状完全消失（CCSQ总分降至0分且维持≥24小时）所经历的总时间。采用描述性统计（中位数及四分位数）及Mann-Whitney U检验比较两组差异。

Measure time point of outcome：

D7 ± 1 follow-up period

Measure method：

It is defined as the total time from the onset of symptoms until all acute upper respiratory tract infection symptoms completely disappear (with the total score of CCSQ dropping to 0 and remaining stable for ≥ 24 hours). Descriptive statistics (median and quartiles) and the Mann-Whitney U test were used to compare the differences between the two groups.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 3 岁 years
最大 Max age 12 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由研究者向法定监护人详细解释研究内容，并对8周岁及以上儿童进行单独告知，充分尊重其个人意愿

Randomization Procedure (please state who generates the random number sequence and by what method)：

The researchers will explain the research content in detail to the legal guardians, and provide separate information to children aged 8 and above, fully respecting their personal wishes.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单盲

Blinding：

Single blind

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

论文正式发表之时

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

When the paper was officially published

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

? 儿童感冒症状问卷 (CCSQ)：作为核心评估工具，问卷条目经过严格的信效度验证，确保评估准确性。 ? 纸质病例报告表 (CRF)：标准化记录研究者、参与者的各项访视指标及临床检查结果。 ? 电子日记卡 (eDiary)：由研究者、参与者监护人每日填写，实时记录患儿每日症状变化、体温波动及用药依从性。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

? Children's Cold Symptom Questionnaire (CCSQ): As a core assessment tool, the questionnaire items have undergone rigorous reliability and validity verification to ensure the accuracy of the assessment. ? Paper Case Report Form (CRF): Standardized for recording various visit indicators and clinical examination results of researchers and participants. ? Electronic Diary Card (eDiary): Filled out daily by researchers and the guardians of participants, it records the daily symptom changes, temperature fluctuations, and medication compliance of the children in real time.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-21 22:10:32